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Completed

NCT Number: NCT03602313

Biomechanical Gait Analysis in Patients Post-Stroke

Randomized trial of patients with cerebrovascular accident (CVA) receiving traditional and body weight supported (BWS) gait training. Participants are enrolled and randomized upon entry into acute care and gait is evaluated within 48 hours of discharge from the rehabilitation hospital. Gait analysis is used to determine which of the two groups achieved gait parameters most similar to the normal gait of an age-matched population.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Potential participants are identified upon admission to acute care post cerebrovascular accident (CVA) and screened for inclusion. Informed consent is obtained from the patient and/or designee. Demographic information is obtained from the medical record, the patient and/or designee by the clinical coordinator. The participant is randomized into traditional gait training group or body weight support (BWS) group. The participant receives the required amount of physical therapy as directed by clinicians at the acute care facility and accrediting agencies.

The traditional gait training group will receive gait training as presently performed without additional modalities. The BWS group will received BWS gait training in lieu of traditional gait training. Participants will be treated in in-patient rehabilitation for a duration as determined by the clinical team; thus, the overall duration of care may be variable between participants. Time spent in gait training activities for both groups will be tracked by both service unit and by time (minutes).

Within 48 hours of discharge from the acute care facility, the participant will be transported to a separate site for kinematic gait analysis using a marker based motion capture system.

The procedure for gait analysis is as follows:

  • Investigators will place reflective markers on the following areas using non-latex adhesive tape: top of the shoulders, bony part of the pelvis on the front and back, hips, front of the thighs, outside of the knees, front of the shins, outside of the ankles, first and fifth toes, and back of each heel.
  • The participant will walk across the room in the gait analysis lab no more than 20 times at his/her choice of pace while the camera system records gait parameters and kinematics. He/she will be allowed to rest as needed during the data collection.
  • The reflective markers and adhesive tape will be removed and the participant thanked for his/her participation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Current in-patient in acute care for Cerebrovascular accident (CVA),
  • Unilateral CVA affecting at least the lower limb, and
  • Medically stable as determined by the rehabilitation physician.

Exclusion criteria

  • Previous (more than 1) CVA with residual lower limb deficit, and
  • Any lower extremity pathology on the affected side other than the effects of the CVA.

Treatment and study plan

Body Weight Support Gait Training

Device

Other names: BSWTT, LiteGait

Traditional Gait Training

Other

Other names: Overground

Primary outcomes

  1. Gait Speed

    Time frame: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.

    Velocity of center of mass of the participant.

  2. Step Length

    Time frame: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.

    Difference in position between the feet at heel strike, in the direction of forward motion.

  3. Step Width

    Time frame: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.

    Difference in position between the feet at heel strike, in the direction normal to the direction of forward motion.

  4. Step Asymmetry

    Time frame: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.

    The ratio of the difference of left and right step length over the stride length.

Secondary outcomes

  1. Gait Units

    Time frame: Measured at discharge, approximately 21 days

    Measure of the quantity of therapy received during the duration of care.

  2. Functional Independence Measure (FIM)

    Time frame: Admission of the FIM is completed within 72 hours of the start of a rehabilitation, and within 75 hours of discharge, approximately 21 days

    A 17 items survey of patient independence in 2 domains, motor and cognition. It is used as a basic indicator of patient disability.

  3. Length of Stay

    Time frame: Approximately 21 days. Determined by the study clinicians based on severity of disability and rate of progress.

    Total duration of care at the acute rehabilitation facility.

Sponsors and collaborators

Lead sponsor

Florida Gulf Coast University

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jul 26, 2018
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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